7.1 Identification And Diversity Of Model Drug
7. RESULTS AND DISCUSSION
7.1 Identification and characterization of model drug
7.1.1 Description: A pale yellow, crystalline powder having bitter taste.
7.1.2 Melting point: The melting point of model drug was found to be 318ºC which confirmed the purity of model drug.
7.1.3 Solubility: Solubility of model drug in distilled water was found to be 10 mg/ml.
7.1.4 Ultraviolet spectrum: The λ max of model drug in 0.1N hydrochloric acid 278nm. Figure 7.1: UV Spectrum of model drug in 0.1 N HCl
The λmax selected for the further analysis in deionized water, 0.1N HCl, and phosphate buffer pH 6.8 was 278 nm.
7.1.5 Infrared spectrum : The drug exhibited characteristic peaks as shown below Figure 7.2: Infrared Spectrum of model drug
Table …show more content…
The friability was observed to be 0.276-0.534 % which was below 1%. This indicated that the formulated tablets had good mechanical resistance.
In wetting time study, it was observed that the tablet containing crospovidone (F7) was fully hydrated after 40 sec of contact with phosphate buffer pH 6.8, and soft throughout. Meanwhile, the centers of the tablets, having croscarmellose sodium, remained dry and hard.
Increased in concentrations of the crospovidone were found to decrease the disintegration time. The reason may be the highly porous structure of crospovidone, allowing it to draw large amounts of water, by a water wicking mechanism, into the porous network of the tablet. Due to this, though, crospovidone swells little, yet it rapidly absorbs water into its network.
In batches where croscarmellose sodium was used as a superdisintegrants, good disintegration time were observed at concentration up to 7 % but a comparative study between crospovidone and croscarmellose sodium shows that least disintegration time were obtained by using …show more content…
7.12.5 Evaluation of ODT of F7
Table 7.21: Evaluation of Optimized ODT F7
Sr. No. Evaluation parameters Result
1 General appearance Orange colored, round flat tablet having 9.5 mm in diameter
2 Thickness (mm) 3.6± 0.2 mm
3 In vivo Disintegration time (sec) 22 ± 1.07
4 In vitro Disintegration time (sec) 28 ± 0.67
5 Uniformity of dispersion Uniformly passed dispersion through sieve no. 22
6 Mouth feel Pleasant
7 Drug content (%) 98.71 ± 0.86
8 Content uniformity (%) 98.22 ± 0.64 Each result based on average of 3 reading ± SD
Orange colored, 9.5 mm round shaped flat tablets were compressed from the optimized formulation F7. Tablet thickness should be controlled within ± 0.2 mm variation of a standard value. Thickness of formulation batch F7 was found in between 3.5-3.7 mm and was found to vary by ± 0.2 mm. Such a close control was observed due to constant tablet press setting across all batches. In vivo disintegration time of batch F7 was found to vary from 20-28 sec. Cooling sensation and pleasant mouth feel was observed. Drug content of batch F7 was found to vary from 97.85-99.57% and content uniformity was found to vary from
7.1 Identification and characterization of model drug
7.1.1 Description: A pale yellow, crystalline powder having bitter taste.
7.1.2 Melting point: The melting point of model drug was found to be 318ºC which confirmed the purity of model drug.
7.1.3 Solubility: Solubility of model drug in distilled water was found to be 10 mg/ml.
7.1.4 Ultraviolet spectrum: The λ max of model drug in 0.1N hydrochloric acid 278nm. Figure 7.1: UV Spectrum of model drug in 0.1 N HCl
The λmax selected for the further analysis in deionized water, 0.1N HCl, and phosphate buffer pH 6.8 was 278 nm.
7.1.5 Infrared spectrum : The drug exhibited characteristic peaks as shown below Figure 7.2: Infrared Spectrum of model drug
Table …show more content…
The friability was observed to be 0.276-0.534 % which was below 1%. This indicated that the formulated tablets had good mechanical resistance.
In wetting time study, it was observed that the tablet containing crospovidone (F7) was fully hydrated after 40 sec of contact with phosphate buffer pH 6.8, and soft throughout. Meanwhile, the centers of the tablets, having croscarmellose sodium, remained dry and hard.
Increased in concentrations of the crospovidone were found to decrease the disintegration time. The reason may be the highly porous structure of crospovidone, allowing it to draw large amounts of water, by a water wicking mechanism, into the porous network of the tablet. Due to this, though, crospovidone swells little, yet it rapidly absorbs water into its network.
In batches where croscarmellose sodium was used as a superdisintegrants, good disintegration time were observed at concentration up to 7 % but a comparative study between crospovidone and croscarmellose sodium shows that least disintegration time were obtained by using …show more content…
7.12.5 Evaluation of ODT of F7
Table 7.21: Evaluation of Optimized ODT F7
Sr. No. Evaluation parameters Result
1 General appearance Orange colored, round flat tablet having 9.5 mm in diameter
2 Thickness (mm) 3.6± 0.2 mm
3 In vivo Disintegration time (sec) 22 ± 1.07
4 In vitro Disintegration time (sec) 28 ± 0.67
5 Uniformity of dispersion Uniformly passed dispersion through sieve no. 22
6 Mouth feel Pleasant
7 Drug content (%) 98.71 ± 0.86
8 Content uniformity (%) 98.22 ± 0.64 Each result based on average of 3 reading ± SD
Orange colored, 9.5 mm round shaped flat tablets were compressed from the optimized formulation F7. Tablet thickness should be controlled within ± 0.2 mm variation of a standard value. Thickness of formulation batch F7 was found in between 3.5-3.7 mm and was found to vary by ± 0.2 mm. Such a close control was observed due to constant tablet press setting across all batches. In vivo disintegration time of batch F7 was found to vary from 20-28 sec. Cooling sensation and pleasant mouth feel was observed. Drug content of batch F7 was found to vary from 97.85-99.57% and content uniformity was found to vary from